FDA to Expand High Performance Computing to Boost Clinical Trial Efficiency

The FDA plans to expand its capabilities in high performance computing to help build disease models and simulate clinical trials — as well as establish a new framework for regenerative medicine this fall — as part of an agency “innovation initiative” announced Friday by Commissioner Scott Gottlieb.

The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. The FDA is also planning to issue additional, updated guidance on how in silico tools can be incorporated into different aspects of drug development.

Today, CDER uses modeling and simulation to predict clinical outcomes, inform clinical trial designs, optimize dosing and evaluate potential adverse events and predict product safety, Gottlieb said.